Antihypertensive Effect of Simvastatin in Hypertensive Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-09-30

Brief Summary

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Few trials have investigated the hypotensive effect of the Statins. Most were not specifically aimed at this pleiotropic effect or had methodological problems. The possible hypotensive effect may explain part of the favorable results of the Statins use on cardiovascular prevention independently from its action on the cholesterol profile.

The purpose of this study is to determine the effect of Simvastatin on the blood pressure

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Detailed Description

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This is a randomized double blind parallel clinical trial where hypertensive patients with controlled or uncontrolled blood pressure and without evidence of target-organ damage will be selected. Subjects will receive Simvastatin 40 mg once daily or placebo and a baseline and eight weeks ABPM will performed. The main outcome will be the difference in systolic BP in the 24h-ABPM.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Simvastatin 40 mg

Group Type ACTIVE_COMPARATOR

Simvastatin 40mg

Intervention Type DRUG

Simvastatin once daily, orally in the morning period, during eigth weeks

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo once daily, orally in the morning period, during eigth weeks

Interventions

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Simvastatin 40mg

Simvastatin once daily, orally in the morning period, during eigth weeks

Intervention Type DRUG

Placebo

Placebo once daily, orally in the morning period, during eigth weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hypertensive patients with controlled or uncontrolled blood pressure

Exclusion Criteria

* Secondary causes of hypertension;
* Systolic Blood pressure \>= 180 mmHg and/or diastolic blood pressure \>= 110 mmHg
* Complain of side effects related to Statins
* Diabetes
* Established target-organ damage (myocardial infarction, stroke, angina, heart failure, peripheral vascular disease)
* Renal disease (creatinine \> 1,5 mgdl).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No